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Endothelial Progenitor Cells

NCT ID: NCT01686269

Last Updated: 2012-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Brief Summary

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Vascular stenosis as a result of neointimal hyperplasia is a major clinical problem that has an impact on multiple and diverse disciplines, including cardiology (coronary restenosis), cardiothoracic and vascular surgery (saphenous vein and polytetrafluoroethylene \[PTFE\] graft failure), neurology (carotid stenosis), nephrology (dialysis access dysfunction), and transplant medicine (chronic allograft rejection in hearts and kidneys). \[1\] In marked contrast to the deleterious effects of smooth muscle progenitor cells on neointimal hyperplasia, circulating endothelial progenitor cells (EPCs) are believed to play an important role in vascular repair and in the inhibition of neointimal hyperplasia. \[2\] Endothelial progenitor cells (EPCs) circulate in adult peripheral blood and contribute to neovascularization. Satoshi et al. have demonstrated that lineage-committed EPCs and CD34-positive mononuclear cells, their putative precursors, are mobilized during an acute ischemic event in humans. \[3\] Reduced levels of circulating EPCs independently predict atherosclerotic disease progression, thus supporting an important role for endogenous vascular repair to modulate the clinical course of coronary artery disease. \[4\] These observations prompt the hypothesis that circulating EPCs may provide an endogenous repair mechanism to counteract surgery-induced endothelial cell injury and to replace dysfunctional endothelium perioperatively. Therefore, the investigators examined whether levels of circulating EPCs correlate with time course and outcomes of coronary artery bypass surgery to establish a clinical role of endogenous endothelial repair mediated by circulating EPCs.

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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Endothelial progenitor cell coronary artery bypass

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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blood collecting

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age from 18 to 85 years
* signed written informed consent
* angiographically documented coronary artery disease and indicated for coronary artery bypass surgery

Exclusion Criteria

* clinical or biochemical evidence for the presence of concomitant inflammatory disease
* chronic renal insufficiency (serum creatinine \> 1.4 mmol/L)
* impaired left ventricular ejection fraction (\< 45%)
* autoimmune or malignant disease
* thrombocytopenia (\< 100 000/L)
* anemia (hemoglobin \< 8.5 g/dL)
* inability to understand the consent form
* previous coronary bypass surgery
* severe peripheral arterial occlusive disease or atrial fibrillation
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Kuan-Ming Chiu, MD

Role: STUDY_DIRECTOR

Far Eastern Memorial Hospital

Locations

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Far Eastern Memorial Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Kuan-MIng Chiu, MD

Role: CONTACT

Phone: 886-2-89667000

Email: [email protected]

Facility Contacts

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Kuan-Ming Chiu, MD

Role: primary

Other Identifiers

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FEMH-95-C-018

Identifier Type: -

Identifier Source: org_study_id